Unanticipated Problems Reporting Policy

Pursuant to Institutional Review Board policy and the Office for Human Research Protections and the Food and Drug Administration guidance and regulations, investigators are required to report all unanticipated problems involving risk to participants or others (including serious protocol deviations) to the Institutional Review Board within 10 business days of discovery. The only exception to this policy is death of a study participant at UMMC. The study-related death of a UMMC research participant must be reported within 48 hours of notice.

An adverse event is considered an unanticipated problem that should be reported if it is:

Serious and

Unexpected and

Related or possibly related to participation in the research and

Suggests that the research places participants or others at greater risk of harm than previously expected.

If review of aggregate events by the data safety monitoring entity for the study indicates: a) that expected events have occurred at a significantly higher frequency or severity than originally expected; or b) if a review of aggregate events necessitates a change in the protocol or consent document, a summary report of those events should also be submitted to the Institutional Review Board.

Reports of other events (for example, events that are expected, identified in the current consent document, due to a disease process, or not related to the study) should not be submitted to the Institutional Review Board, but should be reported to the study sponsor, data safety monitor and FDA, as applicable, and filed in the study’s regulatory binder.

Events that do not meet the definition of an unanticipated problem involving risk to participants or others, including research related injury occurring at a UMMC performance site or to a UMMC study participant, participant complaints, continuing problems, minor protocol deviations and non-compliance with the IRB’s requirements for protecting human research participants should be reported as follows:

Minor deviations and problems should be submitted at the time of continuing review, as instructed on the form.

All other events should be reported in writing via letter or e-mail to the IRB with sufficient detail to allow the reviewer to understand the problem and any actions taken to prevent it from happening again.